In the United States alone, 35 million people a year are treated for sinus infections, or sinusitis, and 7 million of those will suffer from chronic sinusitis and will have minimal response to prescription drug therapies. Current surgical interventions may be expected to, at best, offer only moderate symptomatic improvement but no cure.
Current drug therapies include oral administration as pills and nasal topical administration, neither of which is conducive to delivering adequate concentration of medication to the involved paranasal sinus. In addition to medication, frequent sinus irrigation can be helpful in flushing out debris, irritants and obstructing viscous fluids, but patients are generally not able to adequately perform this procedure at home.
For patients with particularly severe symptoms, surgical drainage may be the only additional option. An early surgical procedure was the Caldwell-Luc procedure, which involves creating a permanent fistula from the base of the paranasal sinus into the oral cavity above the front upper incisors. More recently, other surgical access points to the paranasal sinuses have been attempted. A variety of endoscopic techniques have been developed that access the paranasal sinuses through the nose, including functional endoscopic sinus surgery (FESS) and balloon sinuplasty. All attempt to increase drainage, but utilize different routes or tools. Surgical formation of a fistula between the lacrimal apparatus and a paranasal sinus has been identified as a technique to provide direct access to the paranasal sinus, and through which a variety of medical treatments and medical procedures may be directed to the paranasal sinus. None of these surgical approaches has yet achieved wide-spread acceptance or success, and millions of chronic sinusitis patients continue to suffer long-term disability and discomfort. There continues to be a need for effective and convenient techniques to administer drugs directed to treatment of conditions of the paranasal sinuses.